Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients With Nutritional Risk and Initial Enteral Nutrition Intolerance: A Clinical Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Morbidity of infection
研究概览
简要总结
Patients will be randomized to early PN group or late PN group at day 3 after abdominal surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.
详细描述
Patients after abdominal surgery will attempt enteral nutrition support for 2 days, if she/he can not tolerate 30% of target energy, then she/he will be randomized to early PN group or late PN group at day 3. Patients in early PN group will receive supplemental parenteral nutrition at day 3 while patients in late PN group will not receive supplemental parenteral nutrition until day 8 after abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN or oral or patients are discharged from hospital. The primary and secondary outcomes will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of patients or their legal representatives to participate in this study.
- •Patients undergoing selective operation without trauma
- •Patients following medium or major abdominal surgery
- •NRS 2002≥ 3
排除标准
- •Psychiatric disorders
- •Pregnancy or breast-feeding women
- •Malnutrition
- •Weight loss >10%-15% in 6 months
- •SGA score with stage C
- •Albumin <30g/L
- •Unstable vital signs or unstable hemodynamics (such as systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg after rapid 500 ml crystal or 200 ml gel infusion, or the 50% increase of vascular active drug infusion rate in an hour, etc)
- •Refuse to participate in the study
- •Mortality rates expected to more than 50% in 6 months with malignant or irreversibility diseases
- •Cancer in terminal stage
- •HIV positive at end-stage or CD4 < 50/mm3
- •Cardiopulmonary resuscitation (CPR) before cardiac arrest and nervous system function not fully recovery
- •Four levels of physical activity of the patients defined by New York heart association
- •Rely on breathing machine because of chronic diseases
- •Life expectancy less than 24 hours of dying patients
- •Refractory shock to meet any of the following article
- •The infusion rate of dopamine > 15 ug/kg/min
- •The infusion rate of dobutamine > 15 ug/kg/min
- •The infusion rate of epinephrine and norepinephrine > 30 ug/min
- •The infusion rate of phenylephrine > 50 ug/min
- •The infusion rate of milrinone > 0.5 ug/kg/min
- •The infusion rate of vasopressin > 0.04 U/min
- •Inter aortic ballon pump (IABP)
- •Hepatic insufficiency (alanine/aspartate transaminase 200% above normal range)
- •Renal insufficiency(creatinine 200% above normal range)
- •Metabolic diseases（hyperthyroidism/ hypothyroidism, adrenal cortex disorders)
- •EN can reach 30% of target energy in 48 hours after surgery
- •Burn area exceeding 20% of the patient's body surface
- •Autoimmune diseases or immune dysfunction or history of organ transplantation
- •International standardization ratio (INR) more than 3.0 or platelet count < 30000 cells/mm3 or other hemorrhagic diathesis
- •Intracranial hemorrhage one month before enrolment
- •General contraindications to infusion therapy or history of severe allergy against ingredients of enteral and parenteral nutrition
- •Has already participated in another clinical trial
- •Has started to nutritional support therapy before enrolment
- •Diabetes mellitus (anamnestic and/or under medical treatment)
研究组 & 干预措施
Early PN
Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 after abdominal surgery.
干预措施: Parenteral Nutrition (Other)
Delayed PN
Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 8 after abdominal surgery.
干预措施: Parenteral Nutrition (Other)
结局指标
主要结局
Morbidity of infection
时间窗: From date of randomization until the date of infection from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases
次要结局
- Mortality(From date of randomization until the date of death, assessed up to 2 months after patients discharged from hospital.)
- Length of stay in hospital(From date of operation until the date of patients discharged from hospital, assessed up to 12 months.)
- Scale the frequency of gastrointestinal intolerance(During the intervention, assessed up to 2 months.)
- Scale actual calories intake(During the intervention, assessed up to 2 months.)
- Laboratory examination(At the date of patients enrollment and after intervention, assessed up to 2 months.)
研究者
Wang Xinying
Professor, Chief of Clinical Nutrition Service
Jinling Hospital, China